A Study to Test the Efficacy of the HBV Vaccine and to Look at the Prevalence of HBV Infection

NCT00476411 | Completed DMC

• 1 other identifier: HIV-NAT 036
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The prevalence of Hepatitis B core antigen in the Thai population is about 70 %, no data of isolated Hepatitis B core antigen is reported. Hepatitis B core antigen is observed in 10%-20% of individuals from low endemic areas of HBV infection. However, this prevalence of isolated antiHBc would be higher in endemic area of HBV infection. There is conflicting data of occult HBV infection in HIV infected patients. In Thailand, perinatal transmission is the main route of transmission which is different from developed countries. Therefore, isolated antiHBc in Thai people has longer duration than low prevalence regions. Moreover, HBV genotype C and B is common in this region. If the HBV vaccination could eliminate an occult HBV infection in these individuals, the liver related mortality might be reduced. The prevalence and clinical importance of isolated antiHBc in Thai have not been investigated yet. There is also limited data of HBV vaccine response in this setting.

Conditions

Hepatitis b Virus

Keywords

isolated HBc; HBV vaccine response; occult HBV in isolated antiHBC compared HIV to non HIV

Outcome Measures

Primary Outcomes (1)

• HBV DNA in HIV-infected patients presenting with a serological pattern of isolated anti-HBcAg compare to non HIV patients with isolated antiHBc

  1 year

Secondary Outcomes (3)

• antiHBs titer after 2 month of third dose of HBV vaccine in both 2 groups

  1 year

• liver function test after HAART in HIV patients compare between negative and positive HBV DNA

  1 year

• 3TC resistant after 3TC containing HAART in HIV patients with detectable HBV DNA prior treatment

  1 year

Study Arms (1)

1

EXPERIMENTAL

HBV vaccine

Biological: HBV vaccine

Interventions

HBV vaccine BIOLOGICAL

HBV vaccine 3 doses at month 0, 1, and 6

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-infected adults followed at HIV-NAT and HIV-NAT affiliated hospitals and Un-infected HIV adults followed at chulalongkorn hospital and blood bank
• AntiHBc positive without HBsAg and antiHBs
• Written inform consent

You may not qualify if:

• Patients receiving, or with an anticipated need to receive, any concomitant medications with the potential to decrease the response to HBV vaccine such as long term steroid user, chemotherapy, cancer

Sponsors & Collaborators

• The HIV Netherlands Australia Thailand Research Collaboration: lead

Study Sites (1)

HIV-NAT Thai Red Cross AIDS Research Center

Bangkok, 10330, Thailand

Location

Related Links

• The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Anchalee Avihingsanon, MD

  HIV-NAT, Thai Red Cross AIDS Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2007
• First Posted: May 22, 2007
• Study Start: December 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: December 1, 2009
• Last Updated: July 17, 2020

Record last verified: 2020-07

Locations

TH (1)